<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220705055372N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-19</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of balance training with cognitive task</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of dual task balance training with single task balance training in subjects with anterior cruciate ligament reconstruction: A randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65183</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random block allocation method with volume 4 will be used.

All possible 4 permutations will be listed in two groups. (Permutations 1 to 6 as follows)

A is the intervention group and B is the control group.

1-AABB

2-ABAB

3-BAAB

4-BABA

5-BBAA

6-ABBA
Then, from the random numbers table with random starting point, 6 will be selected between 1 and 6 by accident (either using software or randomaize.com site).For example, if the 6 random numbers obtained are 3 5 4 3 4 6, it will mean that the first four are similar to block 3, the second four are similar to block 5 and ... They'll be allocated, Blinding description: In this study, evaluators, analyzer were kept blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>People or patients with anterior cruciate ligament reconstruction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients receive 60 minutes of treatment for 4 weeks and 3 sessions per week in a total of 12 sessions. In the intervention group, patients are initially treated with conventional physiotherapy for 30 minutes and then perform balance exercises that coincide with cognitive task for 30 minutes. Intervention 2: Control group: patients receive 60 minutes of treatment for 4 weeks and 3 sessions per week in a total of 12 sessions. In the control group, patients are initially treated with conventional physiotherapy for 30 minutes and then perform balance exercises separately for 30 minutes.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is there is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Neda Mostafaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Paramedical Sciences, University Campus, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948964</zip>
        <telephone>+98 51 3884 6710</telephone>
        <email>neda_mostafaee@yahoo.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Amirinejad Robat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazdan Building, Sadeghiyeh18, Sadeghiyeh Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9186391111</zip>
        <telephone>+98 34 3413 1421</telephone>
        <email>amirinezhadmr@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants age between 16 and 50
At least 6 weeks have passed since ACL reconstruction surgery (at least 40 seconds on the injured leg can stand)
Have minimal inflammation
There is a minimum range of motion of 120 degrees for knee flexion
Able to walk without any help
Sensory and motor function of the lower extremity of the person is healthy</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient has neurological problems, heart and respiratory diseases
Have a history of neuromuscular diseases and surgery in the lower extremities
The patient has vision problems and vestibolar disorders
The rate of pain during evaluation on the VAS scale is greater than 2
The patient should take a reduced consciousness and hypnotic drug
Patients have osteoporosis, knee osteoarthritis and fractures in the lower extremities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of cruciate ligament of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: patients receive 60 minutes of treatment for 4 weeks and 3 sessions per week in a total of 12 sessions. In the intervention group, patients are initially treated with conventional physiotherapy for 30 minutes and then perform balance exercises that coincide with cognitive task for 30 minutes.</i_keyword>
      <i_keyword>Control group: patients receive 60 minutes of treatment for 4 weeks and 3 sessions per week in a total of 12 sessions. In the control group, patients are initially treated with conventional physiotherapy for 30 minutes and then perform balance exercises separately for 30 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Star Excursion Balance Test. Timepoint: This assessment is done before and after treatment. Method of measurement: This tool is used as a widely used dynamic test for clinical and research trials that evaluate a person's dynamic balance and this test requires strength, flexibility and depth perception. While standing on one leg (injured leg), the tester must move the other leg along eight directions and the person's displacement will be measured and will be calculated as the person's score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Single Leg Stance on Force Platform. Timepoint: This assessment is done before and after treatment. Method of measurement: The force plate is a tool that measures information about the state of the body and uses oscillation amplitude to evaluate this information. This amplitude is obtained from the minimum and maximum distance from the pressure center recorded by the device, and the lower the amplitude, the better the stability. Another parameter of the force plate is the sway speed, which is defined as the total displacement of the center of pressure on the total time the person has been on the device, and the lower the sway speed, the better the state stability of the individual.</sec_outcome>
      <sec_outcome>Tegner Activity Scale. Timepoint: This assessment is done before and after treatment. Method of measurement: This scale is used to record the activity level of both groups. The numerical amplitude of this scale is in the range of 0-10. The higher the score on this scale, the higher the activity level.</sec_outcome>
      <sec_outcome>Knee Injury and Osteoarthritis Outcome Score (KOOS). Timepoint: This assessment is done before and after treatment. Method of measurement: A questionnaire used to assess the outcome of knee injuries and knee joint function. This questionnaire includes 5 dimensions related to pain, symptoms related to illness, life activities, recreational sports activities and quality of life. The score of this questionnaire is between 0-100, which means the maximum disability score and the score of 100 means that the person has no disability.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-28</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Yazdan Building , Sadeghiyeh18, Sadeghiyeh Blvd, Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
